NICU Antibiotics and Outcomes Trial
Public ClinicalTrials.gov record NCT03997266. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life. In this 802-subject multicenter placebo-controlled randomized clinical trial, the hypothesis to be tested is that the incidence of adverse outcomes is higher in babies receiving empiric antibiotics (EA) in the first week of life compared to babies receiving placebo. The study targets a population of ELBW infants in whom the clinical decision to use or not use EA is currently most challenging -- infants that are clinically stable that did not have a known exposure to intraamniotic infection and were not born preterm for maternal indications. The primary outcome is the composite outcome of late-onset sepsis (LOS), necrotizing enterocolitis (NEC), or death during the index hospitalization. Secondary safety outcomes will include total antibiotic days, days to full enteral feedings, and common morbidities in preterm infants that have previously been linked to EA, e.g. retinopathy of prematurity and bronchopulmonary dysplasia. Weight and length z-score, and head circumference, are standard measures to be collected weekly by clinical team per a standardized protocol.
Study identification
- NCT ID
- NCT03997266
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 359 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 4 Hours
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 4, 2020
- Primary completion
- Jan 14, 2026
- Completion
- Jan 14, 2026
- Last update posted
- Apr 23, 2026
2020 – 2026
United States locations
- U.S. sites
- 14
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| USA Children's and Women's Hospital | Mobile | Alabama | 36688 | — |
| Sharp Mary Birch Hospital for Women & Newborns | San Diego | California | 92123 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06520-8064 | — |
| University of South Flordia Health | Tampa | Florida | 33606 | — |
| University of Louisville Research Foundation Inc./Kosair Charities Pediatric Clinical Research Unit | Louisville | Kentucky | 40202 | — |
| The Trustees of Columbia University in the City of New York | New York | New York | 10032-3702 | — |
| Golisano Children's Hospital at University of Rochester | Rochester | New York | 14642 | — |
| Maria Fareri Children's Hospital at Westchester Medical Center | Valhalla | New York | 10595 | — |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | — |
| Penn State Medical College | Hershey | Pennsylvania | 17033 | — |
| Pennsylvania Hospital/The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Alfred I. duPont for Children of the Nemours Foundation | Philadelphia | Pennsylvania | 19107 | — |
| Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03997266, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 23, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03997266 live on ClinicalTrials.gov.